Events

Recall of BioSync Anatomic Cotton Wedge

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arthrex, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74084
  • Event Risk Class
    Class 2
  • Event Number
    Z-1963-2016
  • Event Initiated Date
    2016-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146251
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bone Wedge - Product Code PLF
  • Reason
    Potential for polystyrene particulate presence.
  • Action
    On 04/22/2016 Arthrex contacted all distributors that received potentially affected devices and instructed them to place the product in quarantine. Distributors were then instructed to return affected devices to Arthrex. Surgeons who have implanted the device will also be receiving a recall notification. Surgeons, risk managers, and distributors received mailed recall notification identifying the recalled products and batches, the reason for recall, and instructions for returning affected product. Customers are to call Arthrex's Customer Service Line (800-934-4404) to obtain return authorization and further instructions. Customers were also required to complete a "Recall Acknowledgement of Receipt" postal card to return to Arthrex, Inc. in an enclosed envelope.

Device

BioSync Anatomic Cotton Wedge
  • Model / Serial
    Catalog #: AR-8948W-2065; Batch #: 10019150; Unique Device Identifier: 00888867202757.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.
  • Product Description
    BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
  • Manufacturer
    Arthrex, Inc.

Manufacturer

Arthrex, Inc.
  • Manufacturer Address
    Arthrex, Inc., 1370 Creekside Blvd, Naples FL 34108-1945
  • Manufacturer Parent Company (2017)
    Arthrex, Inc.
  • Source
    USFDA